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1 Year Trial Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy

Primary Purpose

Diabetic Nephropathies, Hypertension

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Telmisartan
Valsartan
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathies

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Type 2 diabetes mellitus Aged 30-70 years of age Hypertension at screening defined as: an average cuff systolic blood pressure > 130 mmHg and/or diastolic blood pressure >80 mmHg in untreated patients OR patients receiving antihypertensive therapy (i.e., medications specifically prescribed to treat hypertension) Overt nephropathy defined by 24 hour proteinuria >= 900 mg and by serum creatinine below 265 mol/l (3.0 mg/dl) Exclusion Criteria: None

Sites / Locations

  • University Hospital St. Anna
  • University Hospital Hradec Kralove
  • University Hospital Vihohrady
  • General University Hospital
  • District Hospital Tabor
  • Masaryk Hospital
  • Hospital Usti nad Orlici
  • Medical Department
  • Medicinsk afdeling
  • Medicinsk afdeling F, Endokrinologisk
  • Endokrinologisk afdeling
  • Medical Department
  • Chu Sud
  • Centre Hospitalier
  • Hopital Duchenne
  • Hopital Clemenceau
  • Centre Hospitalier
  • Hopital Albert Michalon
  • Hopital A.Mignot
  • Hopital Maison Blanche
  • Hopital Yves Le Foll
  • Hopital Saint Quentin
  • Centre Hospitalier
  • Boehringer Ingelheim Investigational Site
  • Diabetes Klinik Bad Mergentheim
  • Institut fur Klinische Forschung
  • Charite Campus Buch
  • KFH Dialysezentrum
  • Universitatsklinik Heidelberg
  • Boehringer Ingelheim Investigational Site
  • Institut fur Klinische Forschung
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Internist
  • Azienda Ospedaliera Policlinico S. Orsola Malpighi
  • Ospedali Riuniti di Livorno
  • Presidio Ospedaliero Campo di Marte
  • Universita degli Studi "Federico II"
  • Azienda Ospedaliera di Padova
  • IRCCS Policlinico S.Matteo
  • Policlinico Monteluce
  • Azienda Ospedaliera S. Maria degli Angeli
  • Ospedale "S. Maria delle Croci"
  • Universita Tor Vergata
  • Keimyung University Dongsan Medical Center
  • Yonsei University Medical Center
  • Hospital Ipoh
  • University Sains Malaysia
  • Hospital Kuala Lumpur
  • University Malaya Medical Centre
  • Penang General Hospital
  • Hospital Putrajaya
  • Centro Hospitalar de Coimbra
  • Hospital Distrital de Faro
  • Hospital de Santa Maria
  • Hospital de Santa Marta
  • Associac?o Protectora dos Diabeticos de Portugal
  • Hospital Curry Cabral
  • Hospital Pedro Hispano
  • Hospital de S. Jo?o
  • Centro Hospitalar Vila Nova de Gaia
  • Medical Academy named Sechenova I.M.
  • Russian State Medical University
  • Russian State Medical University
  • National Endocrinology Research Center of Russia
  • Russian State Medical University
  • President's Medical Center
  • Russian Cardiology Research Center
  • Russian Academy for Advanced Medical Studies
  • Moscow President's Medical Center
  • Regional Clinical Scientific Research Institute
  • City Hospital of Saint Elizaveta
  • Military Medical Academy
  • NovaMed
  • Ministry Hospital of Internal Affairs
  • Faculty Hospital
  • Faculty Hospital of L. Derer
  • Diabetologic and Internal Clinic
  • Faculty Hospital
  • Hospital Nove Mesto
  • Regional Hospital Nove Zamky
  • MSP-DIAGNOSTIK, Ltd.
  • Faculty Hospital Trnava
  • Hospital Torrecardenas
  • Hospital Ntra. Sra de Sonsoles
  • Hospital Clinico y Provincial de Barcelona
  • Hospital Vall d'Hebron
  • Hospital de Basurto
  • Hospital Universitario Reina Sofia
  • Hospital de Cabuenes
  • Hospital Virgen del Rocio
  • Hospital Universitario La Fe
  • Changhua Christian Hospital
  • Buddhist Tzu Chi Hospital
  • National Cheng Kung University Hospital
  • Mackay Memorial Hospital
  • Chi Mei Medical Center
  • Dnyepropyetrovsk Medical Academy
  • Kharkiv Medical State University
  • Institute of Diabetic pathology problems
  • Institute of Cardiology
  • V.P. Komisarenko Institute of Endocrinology and Metabolism
  • Kyiv Clinical Hospital No. 1
  • Zaporozhye Regional Clinical Hospital

Outcomes

Primary Outcome Measures

Change from baseline (Visit 6) in 24 hour proteinuria, after one year of treatment (study end) with telmisartan 80 mg versus valsartan 160 mg.

Secondary Outcome Measures

Change from baseline in 24-hour urinary albumin excretion rate (UAER).
Change from baseline in 24-hour urinary sodium excretion rate.
Change from baseline in serum creatinine.
Change from baseline in creatinine clearance
Change from baseline in estimated glomerular filtration rate (eGFR).
Change from baseline in plasma asymmetrical dimethylarginine (ADMA) levels.
Change from baseline in urine 8-iso-prostaglandin F2α levels
Change from baseline in serum high sensitive C-reactive protein (CRP) levels.
Time to a composite of a doubling of serum creatinine concentration , end-stage renal disease (ESRD), or all cause death
Time to a composite of morbidity and mortality from cardiovascular causes (myocardial infarction (MI), stroke, first hospitalisation for heart failure or unstable angina, coronary or peripheral revascularisation).
Change from baseline in insulin sensitivity (Homeostasis Model Assessment (HOMA) index).
Change from baseline in plasma adiponectin levels.
Change from baseline in BP endpoints (SBP, DBP and pulse pressure)

Full Information

First Posted
September 9, 2005
Last Updated
November 12, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00153023
Brief Title
1 Year Trial Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy
Official Title
A Prospective, Randomised, Double-blind, Double-dummy, Forced-titration, Multicentre, Parallel Group, One Year Treatment Trial to Investigate the Efficacy of Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy VIVALDI-Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
The general aim of this study is to compare telmisartan 80 mg with valsartan 160 mg in hypertensive patients with type 2 diabetes and overt nephropathy with adjusted blood pressure beyond the target of 130/80 mmHg after one year of treatment. The primary objective of this study is to show that telmisartan 80 mg is at least as effective (i.e., not inferior) and possibly superior to valsartan 160 mg in reducing 24 hour proteinuria after one year of treatment.
Detailed Description
This is a randomised, double-blind, double-dummy, forced titration, multicentre, parallel group trial in patients with essential hypertension, diabetes mellitus type 2 and diabetic nephropathy. After a 4-6 week Run-in period, patients are randomised to one of the treatment groups and receive either Telmisartan 40 - 80 mg or Valsartan 80 - 160 mg. The treatment regimen is a forced titration with the lower dose given for 2 weeks and the higher dose given for the rest of the treatment period summing up to 52 weeks of treatment. During the treatment period, 8 visits to the investigator are scheduled in order to control blood pressure, renal function parameters and safety. In addition, parameters of endothelial function and oxidative stress are measured at baseline, 6 months and after one year of treatment. Study Hypothesis: Non-inferiority of telmisartan 80 mg compared to valsartan 160 mg will be tested using the following set of hypotheses: Null Hypothesis: The overall mean change from baseline in UPER (24 hour urinary protein excretion rate) for telmisartan 80 mg is inferior to that for valsartan 160 mg by 0.5 g/day or more. Alternative Hypothesis: The overall mean change from baseline in UPER (24 hour urinary protein excretion rate) for telmisartan 80 mg is less than 0.5 g/day worse than that for valsartan 160 mg. Comparison(s): In order to test the non-inferiority hypothesis, analysis of covariance with treatment and centre as main effects and baseline as a covariate will be performed. Time-to-event data will be analysed using the log-rank test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathies, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
885 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Telmisartan
Intervention Type
Drug
Intervention Name(s)
Valsartan
Primary Outcome Measure Information:
Title
Change from baseline (Visit 6) in 24 hour proteinuria, after one year of treatment (study end) with telmisartan 80 mg versus valsartan 160 mg.
Time Frame
Baseline, after 1 year of treatment
Secondary Outcome Measure Information:
Title
Change from baseline in 24-hour urinary albumin excretion rate (UAER).
Time Frame
Baseline, after 1 year of treatment
Title
Change from baseline in 24-hour urinary sodium excretion rate.
Time Frame
Baseline, after 1 year of treatment
Title
Change from baseline in serum creatinine.
Time Frame
Baseline, after 1 year of treatment
Title
Change from baseline in creatinine clearance
Time Frame
Baseline, after 1 year of treatment
Title
Change from baseline in estimated glomerular filtration rate (eGFR).
Time Frame
Baseline, after 1 year of treatment
Title
Change from baseline in plasma asymmetrical dimethylarginine (ADMA) levels.
Time Frame
Baseline, after 1 year of treatment
Title
Change from baseline in urine 8-iso-prostaglandin F2α levels
Time Frame
Baseline, after 1 year of treatment
Title
Change from baseline in serum high sensitive C-reactive protein (CRP) levels.
Time Frame
Baseline, after 1 year of treatment
Title
Time to a composite of a doubling of serum creatinine concentration , end-stage renal disease (ESRD), or all cause death
Time Frame
after 1 year of treatment
Title
Time to a composite of morbidity and mortality from cardiovascular causes (myocardial infarction (MI), stroke, first hospitalisation for heart failure or unstable angina, coronary or peripheral revascularisation).
Time Frame
after 1 year of treatment
Title
Change from baseline in insulin sensitivity (Homeostasis Model Assessment (HOMA) index).
Time Frame
Baseline, after 1 year of treatment
Title
Change from baseline in plasma adiponectin levels.
Time Frame
Baseline, after 1 year of treatment
Title
Change from baseline in BP endpoints (SBP, DBP and pulse pressure)
Time Frame
Baseline, after 1 year of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes mellitus Aged 30-70 years of age Hypertension at screening defined as: an average cuff systolic blood pressure > 130 mmHg and/or diastolic blood pressure >80 mmHg in untreated patients OR patients receiving antihypertensive therapy (i.e., medications specifically prescribed to treat hypertension) Overt nephropathy defined by 24 hour proteinuria >= 900 mg and by serum creatinine below 265 mol/l (3.0 mg/dl) Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
B.I. Pharma GmbH & Co. KG
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital St. Anna
City
Brno
ZIP/Postal Code
656 91
Country
Czech Republic
Facility Name
University Hospital Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
University Hospital Vihohrady
City
Prague 10
ZIP/Postal Code
100 34
Country
Czech Republic
Facility Name
General University Hospital
City
Prague 2
ZIP/Postal Code
128 08
Country
Czech Republic
Facility Name
District Hospital Tabor
City
Tabor
ZIP/Postal Code
390 03
Country
Czech Republic
Facility Name
Masaryk Hospital
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czech Republic
Facility Name
Hospital Usti nad Orlici
City
Usti nad Orlici
ZIP/Postal Code
562 18
Country
Czech Republic
Facility Name
Medical Department
City
Copenhagen NV
ZIP/Postal Code
DK-2400
Country
Denmark
Facility Name
Medicinsk afdeling
City
Fredericia
ZIP/Postal Code
DK-7000
Country
Denmark
Facility Name
Medicinsk afdeling F, Endokrinologisk
City
Hiller?d
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Endokrinologisk afdeling
City
Hvidovre
ZIP/Postal Code
DK-2650
Country
Denmark
Facility Name
Medical Department
City
Roskilde
ZIP/Postal Code
DK-4000
Country
Denmark
Facility Name
Chu Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Centre Hospitalier
City
Beauvais
ZIP/Postal Code
60021
Country
France
Facility Name
Hopital Duchenne
City
Boulogne sur Mer cedex
ZIP/Postal Code
62320
Country
France
Facility Name
Hopital Clemenceau
City
Caen cedex 5
ZIP/Postal Code
14033
Country
France
Facility Name
Centre Hospitalier
City
Dunkerque
ZIP/Postal Code
59240
Country
France
Facility Name
Hopital Albert Michalon
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Hopital A.Mignot
City
Le Chesnay
ZIP/Postal Code
78157
Country
France
Facility Name
Hopital Maison Blanche
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
Hopital Yves Le Foll
City
Saint Brieuc cedex 1
ZIP/Postal Code
22023
Country
France
Facility Name
Hopital Saint Quentin
City
Saint Quentin
ZIP/Postal Code
02100
Country
France
Facility Name
Centre Hospitalier
City
Valenciennes
ZIP/Postal Code
59322
Country
France
Facility Name
Boehringer Ingelheim Investigational Site
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Diabetes Klinik Bad Mergentheim
City
Bad Mergentheim
ZIP/Postal Code
97980
Country
Germany
Facility Name
Institut fur Klinische Forschung
City
Berlin
ZIP/Postal Code
10115
Country
Germany
Facility Name
Charite Campus Buch
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
KFH Dialysezentrum
City
Eberswalde
ZIP/Postal Code
16225
Country
Germany
Facility Name
Universitatsklinik Heidelberg
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Facility Name
Institut fur Klinische Forschung
City
Mainz
ZIP/Postal Code
55116
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Munster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Neuwied
ZIP/Postal Code
56564
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Pirna
ZIP/Postal Code
01796
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Riesa
ZIP/Postal Code
01587
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Rosenheim
ZIP/Postal Code
83022
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Saarbrucken
ZIP/Postal Code
66121
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Saarlouis
ZIP/Postal Code
66740
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Sinsheim
ZIP/Postal Code
74889
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Speyer
ZIP/Postal Code
67346
Country
Germany
Facility Name
Internist
City
Wurzburg
ZIP/Postal Code
97072
Country
Germany
Facility Name
Azienda Ospedaliera Policlinico S. Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Ospedali Riuniti di Livorno
City
Livorno
ZIP/Postal Code
57100
Country
Italy
Facility Name
Presidio Ospedaliero Campo di Marte
City
Lucca
ZIP/Postal Code
55100
Country
Italy
Facility Name
Universita degli Studi "Federico II"
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
IRCCS Policlinico S.Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Policlinico Monteluce
City
Perugia
ZIP/Postal Code
06100
Country
Italy
Facility Name
Azienda Ospedaliera S. Maria degli Angeli
City
Pordenone
ZIP/Postal Code
33170
Country
Italy
Facility Name
Ospedale "S. Maria delle Croci"
City
Ravenna
ZIP/Postal Code
48100
Country
Italy
Facility Name
Universita Tor Vergata
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
700712
Country
Korea, Republic of
Facility Name
Yonsei University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Hospital Ipoh
City
Ipoh, Perak
ZIP/Postal Code
30990
Country
Malaysia
Facility Name
University Sains Malaysia
City
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Penang General Hospital
City
Penang
Country
Malaysia
Facility Name
Hospital Putrajaya
City
Selangor
Country
Malaysia
Facility Name
Centro Hospitalar de Coimbra
City
Coimbra
ZIP/Postal Code
3041.853
Country
Portugal
Facility Name
Hospital Distrital de Faro
City
Faro
ZIP/Postal Code
8000-386
Country
Portugal
Facility Name
Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1169-024
Country
Portugal
Facility Name
Hospital de Santa Marta
City
Lisboa
ZIP/Postal Code
1169-024
Country
Portugal
Facility Name
Associac?o Protectora dos Diabeticos de Portugal
City
Lisboa
ZIP/Postal Code
1250
Country
Portugal
Facility Name
Hospital Curry Cabral
City
Lisbon
ZIP/Postal Code
1050-035
Country
Portugal
Facility Name
Hospital Pedro Hispano
City
Matosinhos
ZIP/Postal Code
4460-301
Country
Portugal
Facility Name
Hospital de S. Jo?o
City
Porto
ZIP/Postal Code
4200
Country
Portugal
Facility Name
Centro Hospitalar Vila Nova de Gaia
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Medical Academy named Sechenova I.M.
City
Moscow
ZIP/Postal Code
103030
Country
Russian Federation
Facility Name
Russian State Medical University
City
Moscow
ZIP/Postal Code
107066
Country
Russian Federation
Facility Name
Russian State Medical University
City
Moscow
ZIP/Postal Code
115516
Country
Russian Federation
Facility Name
National Endocrinology Research Center of Russia
City
Moscow
ZIP/Postal Code
117036
Country
Russian Federation
Facility Name
Russian State Medical University
City
Moscow
ZIP/Postal Code
117485
Country
Russian Federation
Facility Name
President's Medical Center
City
Moscow
ZIP/Postal Code
121356
Country
Russian Federation
Facility Name
Russian Cardiology Research Center
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
Russian Academy for Advanced Medical Studies
City
Moscow
ZIP/Postal Code
125315
Country
Russian Federation
Facility Name
Moscow President's Medical Center
City
Moscow
ZIP/Postal Code
129090
Country
Russian Federation
Facility Name
Regional Clinical Scientific Research Institute
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
City Hospital of Saint Elizaveta
City
St. Petersburg
ZIP/Postal Code
195257
Country
Russian Federation
Facility Name
Military Medical Academy
City
St. Petersburg
ZIP/Postal Code
198013
Country
Russian Federation
Facility Name
NovaMed
City
Banska Bystrica
ZIP/Postal Code
974 05
Country
Slovakia
Facility Name
Ministry Hospital of Internal Affairs
City
Bratislava
ZIP/Postal Code
812 72
Country
Slovakia
Facility Name
Faculty Hospital
City
Bratislava
ZIP/Postal Code
81369
Country
Slovakia
Facility Name
Faculty Hospital of L. Derer
City
Bratislava
ZIP/Postal Code
833 05
Country
Slovakia
Facility Name
Diabetologic and Internal Clinic
City
Lucenec
ZIP/Postal Code
984 01
Country
Slovakia
Facility Name
Faculty Hospital
City
Nitra
ZIP/Postal Code
94901
Country
Slovakia
Facility Name
Hospital Nove Mesto
City
Nove Mesto
ZIP/Postal Code
915 01
Country
Slovakia
Facility Name
Regional Hospital Nove Zamky
City
Nove Zamky
ZIP/Postal Code
940 52
Country
Slovakia
Facility Name
MSP-DIAGNOSTIK, Ltd.
City
Trencin
ZIP/Postal Code
91101
Country
Slovakia
Facility Name
Faculty Hospital Trnava
City
Trnava
ZIP/Postal Code
91701
Country
Slovakia
Facility Name
Hospital Torrecardenas
City
Almeria
ZIP/Postal Code
04009
Country
Spain
Facility Name
Hospital Ntra. Sra de Sonsoles
City
Avila
ZIP/Postal Code
05071
Country
Spain
Facility Name
Hospital Clinico y Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08038
Country
Spain
Facility Name
Hospital de Basurto
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital de Cabuenes
City
Gijon
ZIP/Postal Code
33204
Country
Spain
Facility Name
Hospital Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitario La Fe
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Changhua Christian Hospital
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Buddhist Tzu Chi Hospital
City
Hualien City
ZIP/Postal Code
970
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70428
Country
Taiwan
Facility Name
Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
104
Country
Taiwan
Facility Name
Chi Mei Medical Center
City
Taiwan
ZIP/Postal Code
701
Country
Taiwan
Facility Name
Dnyepropyetrovsk Medical Academy
City
Dnyepropetrovsk
ZIP/Postal Code
49044
Country
Ukraine
Facility Name
Kharkiv Medical State University
City
Kharkov
ZIP/Postal Code
61022
Country
Ukraine
Facility Name
Institute of Diabetic pathology problems
City
Kharkov
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Institute of Cardiology
City
Kiev
ZIP/Postal Code
03151
Country
Ukraine
Facility Name
V.P. Komisarenko Institute of Endocrinology and Metabolism
City
Kiev
ZIP/Postal Code
04114
Country
Ukraine
Facility Name
Kyiv Clinical Hospital No. 1
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Zaporozhye Regional Clinical Hospital
City
Zaporozhye
ZIP/Postal Code
69600
Country
Ukraine

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/502/502.396_U06-1367.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/502/502.396_literature.pdf
Description
Related Info

Learn more about this trial

1 Year Trial Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy

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